Economic Operators
12:05 PM - 1:35 PMTue
Speakers
Michael Gyr
Nic Pugliano
Regulatory Affairs Associate
W. L. Gore
Caroline Prisk
Regulatory Affairs & Quality Assurance
Stryker
Erick Vollebregt
Axon Lawyers
Keith Morel, Ph.D.
Vice President, Regulatory Compliance
QServe
. How can large manufacturers handle the various verifications the manufacturer, importer and distributor need to perform and avoid duplication? (related to MEDTECH Europe document) . IS "placing on the market" and "making available" triggered by PHYSICAL ownership AS WELL as legal ownership? . Are 3rd Party logistics providers (e.g. Healthlink, Rhenus, UPS) who are Fulfillment Service Providers also distributors? . Challenges with the point of "placing on the market" for capital equipment (and devices which must be installed) - who then is the importer? Who is the distributor? . Should Economic Operators be managed through the Supplier Management process within the QMS (ISO 13485:2016 clause 7.4)?